裂叶独活的质量标准研究

Study on the quality standard of Heracleum millefolium

目的首次建立裂叶独活的质量标准。方法采用性状、显微、薄层色谱等经典方法鉴别裂叶独活;按2020年版《中国药典》中四部通则法测定裂叶独活的水分、总灰分、酸不溶性灰分、浸出物等;采用UPLC法测定指标成分芦丁的含量。结果裂叶独活的鉴别特征显著,可作为该药材的鉴别方法;并初步拟定了裂叶独活中的水分不得过13.0%,总灰分不得过15.0%,酸不溶性灰分不得过4.0%,浸出物不得少于18.0%;芦丁的含量不得少于1.3%。结论所用方法的准确性、重复性、稳定性均较好,可为裂叶独活的质量标准建立提供依据。

OBJECTIVE To establish the quality standard of Heracleum millefolium Diels for the first time.METHODS Classical methods such as morphological identification,microscopic identification,and thin-layer chromatography were used to determine the characteristics of H.millefolium.The testing methods from the general principles of Part Four of the 2020 edition of the Chinese Pharmacopoeia were used to measure moisture content,total ash,acid-insoluble ash,and extractives in H.millefolium.The ultra-high-performance liquid chromatography method was applied to determine the content of the marker compound,rutin.RESULTS The distinguishing features of H.millefolium were significant and could be utilized as identification methods for this medicinal herb.Preliminary specifications for H.millefolium were proposed,indicating that the moisture content not exceeding 13.0%,total ash not exceeding 15.0%,acid-insoluble ash not exceeding 4.0%,extractives not less than 18.0%,and rutin content not less than 1.3%.CONCLUSION The established methods demonstrate accuracy,reproducibility and stability,providing a scientific basis for the establishment of quality standards for H.millefolium.